Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Bosentan
Drug ID BADD_D00285
Description Bosentan is a dual endothelin receptor antagonist marketed under the trade name Tracleer by Actelion Pharmaceuticals. Bosentan is used to treat pulmonary hypertension by blocking the action of endothelin molecules that would otherwise promote narrowing of the blood vessels and lead to high blood pressure.
Indications and Usage Used in the treatment of pulmonary arterial hypertension (PAH), to improve exercise ability and to decrease the rate of clinical worsening (in patients with WHO Class III or IV symptoms).
Marketing Status approved; investigational
ATC Code C02KX01
DrugBank ID DB00559
KEGG ID D01227; D07538
MeSH ID D000077300
PubChem ID 104865
TTD Drug ID D0U4CE
NDC Product Code 0591-2511; 65015-753; 0591-2512; 47335-039; 66215-103; 68382-447; 47335-038; 66215-102; 66215-232; 49884-058; 68180-386; 49884-059; 65162-873; 68180-387; 0054-0521; 65162-874; 70771-1017; 14501-0041; 70771-1018; 53104-7703; 66215-101; 0054-0520; 66039-870; 68382-446; 65015-770; 82245-0104
UNII Q326023R30
Synonyms Bosentan | 4-t-Butyl-N-(6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide | Bosentan Monohydrate | Tracleer | Bosentan Anhydrous | Ro 47-0203 | Ro 47 0203 | Ro 470203 | Ro-47-0203
Chemical Information
Molecular Formula C27H29N5O6S
CAS Registry Number 147536-97-8
SMILES CC(C)(C)C1=CC=C(C=C1)S(=O)(=O)NC2=C(C(=NC(=N2)C3=NC=CC=N3)OCCO)OC4=CC=CC=C4OC
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abnormal faeces07.01.03.0010.000469%Not Available
Acute pulmonary oedema22.01.03.005; 02.05.02.0040.000361%Not Available
Acute respiratory distress syndrome24.03.02.034; 10.02.01.067; 22.01.03.0010.000421%
Acute respiratory failure22.02.06.001; 14.01.04.0040.002250%Not Available
Adenocarcinoma16.16.01.0040.000120%Not Available
Amyloidosis10.02.05.0010.000120%Not Available
Anaemia01.03.02.0010.007257%
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Aneurysm24.02.01.0010.000361%Not Available
Angina pectoris24.04.04.002; 02.02.02.0020.000722%
Angina unstable24.04.04.004; 02.02.02.0040.000120%Not Available
Angioedema23.04.01.001; 10.01.05.009; 22.04.02.008--Not Available
Anuria20.01.03.0020.000241%Not Available
Anxiety19.06.02.002--
Aortic aneurysm24.02.03.0010.000120%Not Available
Aortic stenosis24.04.01.0010.000421%Not Available
Aortic valve stenosis02.07.03.0040.000181%Not Available
Aphonia19.19.01.002; 17.02.08.009; 22.12.03.0010.000385%
Arrhythmia02.03.02.0010.002407%Not Available
Arthralgia15.01.02.001--
Arthritis15.01.01.0010.001938%
Arthropathy15.01.01.0030.001396%Not Available
Ascites07.07.01.001; 02.05.04.002; 09.01.05.0030.000963%
Asphyxia22.02.02.001; 12.01.08.0110.000181%Not Available
Aspiration22.02.07.0070.000421%
Asthenia08.01.01.0010.008219%Not Available
Asthma22.03.01.002; 10.01.03.0100.002876%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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